Interesting Opportunity to Try to Shape the WHO’s Scheduling of CBD (and Possibly Domestic Law Too)

The World Health Organization (WHO) is apparently reviewing the scheduling of Cannabidiol (CBD) and 16 other drugs under the 1971 Convention on Psychotropic Substances. Prior to a meeting of the relevant WHO committee in early November, the WHO has asked member states (including the U.S.) for input. The Food and Drug Administration (FDA) is responsible for coordinating the United States’ response. To fulfill its responsibility, the FDA has issued a public call for comments “concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use” of CBD (and the 16 other substances). The call for comments can be found here. Comments may be submitted electronically on the website (see upper right hand corner). Already more than 1,200 comments have been submitted.

I don’t know what sort of comments would convince the FDA to push for re-scheduling under the Convention. As discussed in Chapter 5 of the book (pages 195-203), the FDA doesn’t put much stock in personal anecdotes when making scheduling recommendations under domestic law (i.e., the CSA). For better or worse, it generally demands large scale, double-blind, well-controlled studies to demonstrate the medical efficacy of a drug—a demonstration that is needed to move a drug off of Schedule I (see pages 200-201).

And if the WHO decides to reschedule CBD under the Convention, it’s not clear what impact (if any) it would have on scheduling under the CSA. The relationship between the CSA and the Convention is detailed in 21 U.S.C. § 811. As discussed in the book (pages 272-275), the CSA seemingly employs the Convention as a floor, but not a ceiling. In other words, it seemingly requires the FDA/DEA to regulate drugs at least as stringently as called for by the Convention, but it does not similarly obligate those agencies to relax federal controls on a drug just because the Convention believes a softer approach is warranted (say, because of the drug’s medical utility).

So with those caveats in mind, let me say that while this might be much of an opportunity to shape the law, it might at least be a good opportunity to teach about how to shape the law by submitting comments to a federal regulatory agency.

Hat tip to Vincente Sederberg, which sent an email earlier this week announcing the call and proposing to help coordinate comments. You can contact the firm here.